In this 3-Hour Virtual Seminar you will learn about Life Science Regulations and the Regulatory Processes in Japan, also how Japan interacts with and utilizes ICH standards and how they relate with other national regulatory agencies.

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Overview:

This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

The information presented will help you gain a comprehensive understanding of the Regulatory Structure, Product Classification, Clinical Trial Requirements, Marketing Authorization Procedures, Variations Processing, License Renewals, GMP requirements and cultural working aspects within the Regulatory Environment in Japan. It will prepare you for regulatory approval processes, Agency meetings, the complexities of running clinical studies, the importance of partner selection and also add the cultural knowledge needed for success in-country.

The recent changes made by PMDA to be more sponsor and applicant-friendly, along with the impact this has had on dossier review times, will be shared. Real world experiences on actual interactions with the Agency, since these changes have been implemented, will also be discussed.

Learning Objective:
Attendees will leave this Course clearly understanding the Regulatory Procedures necessary to be successful in getting your products to market in a timely fashion. This Course has been updated to provide participants with competitive insight into:

The impact of the PAL to PMDL Law change to applicants

Who can legally register Life Science products in Japan

If you want to be the legal License holder, what will you need: establishment office & personnel type

When will additional clinical trials be needed on products and on which ones

Can you expect a GMP inspection of your facility by PMDA staff; updates to GMP Regulation & Guidelines

What are your post-marketing responsibilities as a License Holder

How best to work with the Authorities from a Business and Cultural Aspect

Course Agenda:

Overview of Healthcare Systems

Regulatory Agencies Structure and Responsibilities

Pharmaceutical Regulations

Country Establishment Licensing & Procedures

Japan and ICH (International Conference on Harmonization)

Drug Development Process

How to Apply for Clinical Trials

The Clinical Trial Application

Amending the CTA

Conducting Meetings with the Agency

Agency Review Process for Decision-Making

Clinical Trial Start-up

GCP Requirements

Importing IMP into Japan

Product Labeling Requirements

Conducting Clinical Trials

Marketing Authorization Procedures (Drugs & Devices)

Considerations for Orphan Drugs, Biologics and Generics

GMP Requirements

Post-Marketing Responsibilities

Aspects of Asian Business Culture

Effectively Working with the Regulators

Summary / Final Comments

Wrap-Up Questions

Who Will Benefit:
This webinar will benefit Project Team Members, whose specific functional discipline comes from:

Global Business Development Personnel

Commercial & Executive Management

Country Managers

Clinical Operations Staff

Quality Assurance Personnel

Monitors / CRAs

Regulatory Affairs Personnel

Pharmacovigilance Reporting Personnel

Global Supply Chain Personnel

Manufacturing Personnel

CRO's,Consultants

Speaker Profile

Robert J. Russell is a Global Regulatory and CMC expert with 28 years of prior industry experience in international regulatory management and compliance, global business development and global supply chain management. Mr. Russell formerly held senior leadership positions, in these functional areas, at Dow Pharmaceuticals and Cordis-Dow Medical Devices.

His experience and knowledge span Healthcare Authority's requirements and regulatory processes across Life Science products.
For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries.
He holds a BS / MS in Chemistry."